FDA Commissioner Plans to Leave Next Month

The Post’s Laurie McGinley, Lenny Bernstein, and Josh Dawsey wrote, in an article published at 3:03 PM eastern time on Tuesday, that “The resignation was not sought by the White House. A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave. While Gottlieb had some policy disagreements with the White House,” the Post’s reporters wrote, “he is well respected, and could even be asked to take another post, said two officials. Gottlieb declined to comment on that possibility.”

Staff reporters from POLITICO reported, in an article published online at 3:44 PM eastern time, that “FDA Commissioner Scott Gottlieb will step down in about a month, leaving a void atop a $5 billion agency that regulates drugs, medical devices, cosmetics, food and other consumer products. In a resignation letter to HHS [Health and Human Services] Secretary Alex Azar, Gottlieb noted his work to reduce tobacco use, discourage teen use of e-cigarettes, address the opioid epidemic and improve access to generic drugs.” In that letter, according to the POLITICO staff, Gottlieb wrote, "I'm confident that the FDA will continue to advance all these efforts, and many other goals.” According to the report, Secretary Azar called Gottlieb an "exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation."

And CNN’s Susan Scutti and Jeremy Diamond, in a report published online at 3:46 PM eastern time, said, quoting the “administration official familiar with the situation,” as stating that “This official said this has been in the works for several months. Gottlieb has been commuting weekly to Washington from his home in Connecticut and is leaving to spend more time with his family, the official said.” Gottlieb previously served as the agency's deputy commissioner for medical and scientific affairs.

During his tenure as commissioner, Gottlieb approved a record number of treatments and drugs and advanced policies to confront opioid addiction and prevent youth e-cigarettes use. He also faced the longest government shutdown in history.

And Jessie Hellmann and Nathaniel Weixel, in a report in The Hill online published at 3:12 PM eastern, wrote that “Gottlieb, a physician, has been one of President Trump’s most popular appointments and appeared to be widely liked within Congress by both Democrats and Republicans. He has led the agency’s response to the opioid epidemic, and recently has been cracking down on youth vaping. During his confirmation process,” Hellmann and Weixel wrote, “congressional Democrats and outside groups sounded the alarm about Gottlieb’s industry connections, warning they pose major conflicts of interest. He had investments in 20 different health-care companies that made products regulated by the agency. But he won over skeptics with his focus on bringing down the high drug prices and reducing youth smoking rates.”

But Sheila Kaplan and Jan Hoffman wrote in a report in The New York Times that “Dr. Gottlieb has been subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes. A coalition of influential conservative groups recently asked the White House to block some key parts of the F.D.A.’s strategy to prevent youths from vaping. Republican Senator Richard Burr blasted the commissioner on the Senate floor for his proposal to ban menthol cigarettes.”

Seema Verma, Administrator of the federal Centers for Medicare and Medicaid Services (CMS), released a statement in which she said that "Scott has been both a great leader as FDA Commissioner and a wonderful friend. I am honored and privileged to have had the opportunity to work alongside him and see all that he has accomplished for the American people to spur medical innovation, increase access to generic drugs, and advance many other public health priorities. I join the entire HHS family in thanking him for his service.”

Later Tuesday evening, the Charlotte-based Premier Inc. health alliance issued a statement, in which the organization said that “Members of the Premier alliance wish to extend their gratitude to FDA Commissioner Scott Gottlieb for his superb leadership of the agency. From working to speed approval of generics and biosimilars, to establishing an expedited approval process for shortage drugs, to expediting the approval of new drugs, to cracking down on abuses of Citizen’s Petitions and the Risk Evaluation and Mitigation Strategies, to exposing pay-for-delay deals, to undertaking a serious effort to assess and remedy the causes of drug shortages, to advancing real-world evidence, Mr. Gottlieb has left an indelible mark. His work will create greater competition for drugs and reduce their prices. Thank you for your leadership.”

Dr. Gottlieb had been working to move the FDA forward in a number of areas. As Managing Editor Rajiv Leventhal reported on Jan. 10 in Healthcare Innovation, “The U.S. Food and Drug Administration (FDA) has drafted a regulatory framework to test new approaches for the review of digital health device applications. In 2017,” Leventhal wrote, “the FDA released its Digital Health Innovation Action Plan, while also unveiling a new precertification pilot program that would soften the regulatory requirements for digital health companies with a track record of developing and testing quality products. The purpose of FDA’s Software Pre-Cert pilot is to leverage customer input to develop a program that can help reduce the time and cost of market entry for software developers that FDA determines reliably manufacture high-quality, safe and effective digital health devices while providing appropriate patient safeguards, the agency said at the time.”

And prior to that, on Apr. 26, 2018, Senior Contributing Editor David Raths had noted, in a report on the Health Datapalooza 2018 conference, that “Scott Gottlieb, commissioner of the U.S. Food and Drug Administration, kicked off the 2018 Health Datapalooza conference in Washington, D.C., on April 26 by announcing several new efforts at FDA to both streamline regulation of digital health tools and incorporate digital technology into the drug and device review processes. In the first-ever presentation by an FDA commissioner to the Datapalooza conference, Gottlieb began by quoting Stanford University computer scientist Roy Amara, who said that we tend to overestimate the impact of a new technology in the short run, but we underestimate it in the long run.” It was in April 2018 that the FDA had first drafted a regulatory framework for the Pre-Cert program.

This is a developing story. Healthcare Innovation will update it as more information becomes available.